Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With FMR (MARCH)

HVR Cardio Oy

Status: Enrolling

Conditions: Mitral Valve Regurgitation (Degenerative or Functional)

Treatments: Device: Transcatheter Mitral Valve Repair

Study type: Interventional

Funder types: Industry

Identifiers

NCT07188233

CIP-2023-008

Details and patient eligibility

About

Patients with functional mitral regurgitation classified as moderate to severe (3+) or severe (4+) that are symptomatic (NYHA Class II-IV) will be evaluated for treatment using the CathHELIX Transcatheter Mitral Annuloplasty System.

Enrollment: 5 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe (3+) or severe (4+) functional mitral regurgitation
• Left ventricular ejection fraction ≥30%
• Symptomatic New York Heart Association (NYHA) Class II to IV).

Exclusion criteria

• Oxygen dependent for COPD
• Active or suspected endocarditis
• Severe symptomatic carotid stenosis
• Has undergone heart transplantation.
• Severe calcification of the mitral annulus or leaflets
• Coronary sinus anatomy that may preclude proper treatment with the device

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Single Arm

Other group

Treatment:

Device: Transcatheter Mitral Valve Repair